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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1970-05-21- to 1970-06-01
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non-GLP study, similar to OECD Guideline. For justification of read across see section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report date:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Oleic acid
EC Number:
204-007-1
EC Name:
Oleic acid
Cas Number:
112-80-1
Molecular formula:
C18H34O2
IUPAC Name:
octadec-9-enoic acid
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Fasting period before study: 24 hours
- Weight at study initiation: 200-300 g
- Housing: 5 animals per cage

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
4, 8, 16, 32, 48, 64 mL/kg, these values correlate to the following: 5262.125, 10524.25, 21048.5, 42097, 63145.5, 84194 mg/kg bw
No. of animals per sex per dose:
5 animals per dose including both male and female animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD0
Effect level:
32 mL/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
47.3 mL/kg bw
Based on:
test mat.
95% CL:
> 40.9 - < 54.7
Remarks on result:
other: 47.3 mL/ kg bw can be converted to 42097 mg/kg bw using the densitiy of the substance (0.89 g/cm^3 = densitiy of CAS 112- 80-1)
Sex:
male/female
Dose descriptor:
LD100
Effect level:
64 mL/kg bw
Based on:
test mat.
Mortality:
Mortality occured from the 40 mL/kg bw dose group onwards. 1 animal of that dose group died on day 2, 3 animals of the 48 mL/kg bw dose group and all animals of the 64 mL/kg bw dose group died on day 1.
Clinical signs:
All dosage levels from 16 mL/kg and above had nasal hemorrhage, crustated occular areas, oozed urine and appeared to be debilitated prior to death.
Body weight:
no data
Gross pathology:
no data

Applicant's summary and conclusion